A Trial to Evaluate the Effect of C21 on Endothelial Dysfunction in Subjects With Type 2 Diabetes

Vicore Pharma

Status and phase

Completed

Phase 1

Conditions

Endothelial Dysfunction

Type2diabetes

Treatments

Drug: C21

Study type

Interventional

Funder types

Industry

Identifiers

NCT05831644

VP-C21-013

2023-000168-77 (EudraCT Number)

Details and patient eligibility

About

This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).

Enrollment

11 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patient aged ≥ 40 years at the time of the screening visit (Visit 1).
Documented diagnosed with T2DM prior to the screening visit (Visit 1).
An RHI score ≤ 2 as assessed by EndoPAT at the time of the screening visit (Visit 1).

Exclusion criteria

Known, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 (cluster of differentiation 4) count <500 cells/mm³).
Impaired hepatic function or clinically significant liver disease, which in the investigator's opinion makes the subject inappropriate for this trial.
Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2).
Prolonged QTcF (QT interval with Fridericia's correction) (>450 ms), atrial fibrillation, clinically significant arrhythmia or other clinically significant abnormality in the resting ECG (electrocardiogram) at screening (Visit 1), as judged by the investigator.
Unstable or deteriorating cardiac condition.
Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.